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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Cardiovascular Working Party Signs off on Final Reflection Paper, Guidelines

The Committee for Medicinal Products for Human Use (CHMP) has adopted a pair of final regulatory documents created by the Cardiovascular Working Party (CWP). Most significantly, the committee has adopted final guidelines on clinical trials of treatments for venous thromboembolism (VTE).

Having been adopted by CHMP late in February, the venous thromboembolic disease guideline is due to come into force on 1 September. The document will replace guidelines introduced in 2000, when advances in research into venous thromboembolic disease and the evolution of related texts have rendered sections of the original file outdated. Specifically, CWP has tried to harmonize the guideline with the content of new or revised European Medicines Agency (EMA) texts regarding the clinical development of antithrombotics, while also bringing it into line with scientific advances.

This process has resulted in a clarification of the distinction between initial and extended treatment of venous thromboembolism. Initial treatment spans the first three to six months. Once this phase of care is completed, any intervention to prevent recurrences is classed as an extended treatment. The update clarifies other distinctions, too. Superficial vein thrombosis, a condition closely linked to the deep vein thrombosis and pulmonary embolism that can manifest in venous thromboembolism, is discussed in the context of its specific clinical development considerations.

CWP has also used the update as an opportunity to discuss the role of alternative imaging techniques, such as magnetic resonance venography, in the diagnosis of deep vein thrombosis and pulmonary embolism, as well as what control drugs are suitable for use in comparative clinical trials. Finally, the new text includes a standardized definition of bleeding events, including details of how to measure blood loss, and a section covering secondary safety endpoints of relevance. The safety endpoint section is a reflection of some of the side effects associated with new antithrombotics.

CHMP adopted the guideline alongside the final version of a reflection paper created by CWP. The reflection paper covers the assessment of the cardiovascular safety profile of medicinal products, a topic CWP felt needed addressing given the issues that have arisen from long-term use of certain drugs over the past decade. Regulators may request dedicated cardiac outcome trials of products that are subject to safety concerns.

EDQM Revises Guidance Ahead of Discontinuation of CESP 1.0

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has revised its guidance on the Common European Submission Platform (CESP), ahead of the discontinuation of version 1.0 of the system. An old version of the submission platform is due go offline on 1 April, at which time organizations using the system should begin following the new EDQM guidance.

CESP 2.0, the latest version of the submission platform through which applicants can communicate with all European regulatory agencies, has been in use alongside the previous iteration of the system since October 2015. The new version adds features such as real-time delivery tracking and reporting, while also lessening its reliance on Java. As a result, CESP 2.0 will only run on browsers that support HTML5. Now, with CESP 1.0 being phased out, users will need to make sure their browsers are up to date, while also adapting their practices to the new capabilities and features of version 2.0.

In its new guidance, EDQM has adapted its advice to support this process. Notable changes to the old text include an expansion of the list of file compression software programs that applicants can use to reduce the size of their documents before they are uploaded to the system. In the past, applicants were restricted to Microsoft Compressed Folders and WinZip. When using CESP 2.0, applicants can upload files that were compressed using other popular zipping programs. WinRar and 7-Zip are listed by name, while the system also includes an option for “other” software.

EDQM has also updated the web address of CESP and added a reference to the fact that applicants can transfer documents using an sFTP client. However, given the range of sFTP client software that is available, EDQM has opted against providing a detailed overview of how to transfer files this way. Instead, the file transfer section is limited to the use of a web-based system, as it was in the earlier guidance. The section, like the rest of the text, has been updated cosmetically, notably through the inclusion of screengrabs from CESP 2.0, but the content is largely unchanged.

Siemens and Roche have issued field safety notices (FSN) after recognizing that the breast cancer drug Faslodex (fulvestrant) may cause assays to deliver falsely elevated estradiol results. In alerting users to the problem, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) noted that estradiol assays from other manufacturers may have the same issue.

The problem came to light after Siemens and Roche, which collectively supply six affected assays to the UK, observed high levels of estradiol in the results of patients taking Faslodex, a breast cancer drug for postmenopausal women sold by AstraZeneca. Fulvestrant, the active ingredient in Faslodex, has a similar chemical structure to estradiol. Consequently, it is thought that fulvestrant may cross-react with the antibodies used in estradiol assays.

For healthcare professionals, this interference may result in the generation of data that leads them to make false deductions about the menopausal status of a patient. With Faslodex being approved for use in postmenopausal women, such a false deduction could result in the physician unnecessarily changing the treatment regimen. To avoid this scenario, MHRA is advising healthcare professionals to mention a patient is taking Faslodex when requesting a test.

In some cases, it may be necessary to reassess the menopausal status of patients who are taking the drug using an alternative method. MHRA is advising laboratory staff to use a method such as liquid chromatography-mass spectrometry to measure the estradiol levels of patients who are on Faslodex.

Other News:

The European Pharmacopoeia has elected Dr. Tobias Gosdschan as its chair for a three-year term starting in June. Having won the election, Dr. Gosdschan is set to become the first Swiss national to lead the European Pharmacopoeia in the more than 50-year history of the organization. Dr. Gosdschan won the election on the strength of his work leading the pharmacopoeia of the Swiss Agency for Therapeutic Products (Swissmedic). Swissmedic Statement (German)

The Committee of Veterinary Medicinal Products (CVMP) has adopted a reflection paper on poorly extractable and non-radiolabeled substances. CVMP first drafted the reflection paper to address issues arising from the propensity for some veterinary medical products to strongly adsorb to the soil matrix. As this makes it hard to extract the substance from the soil, CVMP is proposing to put together a practical strategy for dealing with the issue. Reflection Paper

The United Kingdom National Institute for Health and Care Excellence (NICE) is planning to withdraw its support for acupuncture as a first-line treatment for back pain. NICE made the proposal in a draft guideline that also suggests reclassifying paracetamol as a second-line treatment. PharmaTimes

Anika Therapeutics has received a CE Mark for Cingal, a medical device designed to treat pain associated with osteoarthritis of the knee. The device combines cross-linked sodium hyaluronate and triamcinolone hexacetonide. Press Release